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NCT Number: NCT07629648

Reducing Red Blood Cell Transfusion Requirements for Adults Undergoing Surgical Resection of the Liver - A Quality Improvement Project

The goal of this clinical trial is to determine if implementing a controlled blood removal protocol (i.e. hypovolemic phlebotomy [HP] where approximately 10% of the patient's blood is removed and reinfused following hepatic resection as described in the PRICE-2 clinical trial) will reduce the rate of blood transfusions in liver resection surgery at Kingston Health Sciences Centre. Our goals (not included in the PRICE-2 trial) are as follows:

* Improved monitoring of how the body responds during surgery following controlled blood removal. We will conduct blood tests to look at oxygen, carbon dioxide, lactate, and acid (pH) levels in the blood as well as urine output. * Standardized guidelines for how fluids and blood pressure medications are used during surgery to reduce blood loss and keep hemodynamics stable. * Monitor patients' recovery following surgery to track complications, injury to the heart, length of hospital stay, and outcomes for up to 90 days. We will also compare long-term recurrence rate of liver cancer compared to patients in the past at our site who did not receive the controlled blood removal (i.e., HP) prior to surgery.

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Key information

Conditions

Hepatectomy Blood Cells Transfusion Blood Loss, Surgical Hemorrhage Intraoperative Bleeding Intraoperative Complications Intraoperative Monitoring Pathologic Processes Pathological Conditions, Signs and Symptoms Phlebotomy Transfusion Requirements

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver resection in this study is defined according to the PRICE-2 trial, involving 3 or more liver segments, such as right posterior sectionectomy (of segments VI and VII) as well as central resections involving segments IVb and V, along with expected blood loss of >250 mL
  • in patients with known liver cirrhosis, resection of a full segment was included.

Exclusion criteria

(defined according to the PRICE-2 trial):

  • current cardiac condition (e.g., MI within the last 6 months, hypertrophic cardiomyopathy, severe valvular disease, or other unstable coronary syndromes)
  • history of cerebrovascular disease (CVA within the past 6 months or severe carotid stenosis with more than 70% occlusion)
  • history of significant peripheral vascular disease (not yet revascularized with regular/ongoing claudication)
  • A current pregnancy
  • A documented, patient-declared refusal to undergo phlebotomy and transfusion
  • preoperative autologous blood donation
  • presence of active infection
  • preoperative hemoglobin <100 g/L
  • GFR <60 mL/min
  • platelets count <100 × 109/L
  • Uncorrectable coagulopathies or other decompensated cardiac or respiratory conditions that would contraindicate acute volume depletion
  • undergoing emergency surgery
  • planned intraoperative use of cell salvage
  • inability to participate in follow up
  • in the case of repeat liver resections, previous participation in the trial

Treatment and study plan

Primary outcomes

  1. Reduction of intraoperative red blood cell (RBC) transfusion rates.

    Time frame: Perioperatively, from hospital admission to discharge.

    To change intraoperative transfusion rates (representing a 38% reduction based on PRICE-2 trial) in elective hepatectomies for cancer at KHSC upon implementation of a standardized hypovolemic phlebotomy protocol. In so doing, we aim to make our local transfusion rate in line with the average transfusion rate across centers in Ontario, Canada.

Secondary outcomes

  1. Rate of change in pH based on serial arterial blood gases during hepatectomy.

    Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.

    Intraoperative assessment of changes in pH based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.

  2. Rate of change in PaO2 and PaCO2 (mmHg) based on serial arterial blood gases during hepatectomy.

    Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.

    Intraoperative assessment of changes in PaO2 and PaCO2 (mmHg) levels based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.

  3. Rate of change in serum lactate (mmol/L) based on serial arterial blood gases during hepatectomy.

    Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.

    Intraoperative assessment of changes in lactate (mmol/L) levels based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.

  4. Rate of change in urine output (mL) during hepatectomy.

    Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.

    Intraoperative assessment of changes in urine output (mL) relative to the volume of blood removed during hepatectomy.

  5. Total dose of vasopressors (ephedrine, phenylephrine, norepinephrine, epinephrine, vasopressin) required to maintain a mean arterial pressure (MAP) target of ≥65 mmHg intraoperatively during hypovolemic phlebotomy hepatectomy.

    Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.

    Track total dose (mg/mcg/units) of vasopressors (ephedrine, phenylephrine, norepinephrine, epinephrine, vasopressin) required intraoperatively to maintain a target MAP ≥65 mmHg during hypovolemic phlebotomy hepatectomy.

  6. Incidence of in-hospital postoperative complications following hypovolemic phlebotomy.

    Time frame: Perioperatively, from completion of surgery to hospital discharge.

    Track postoperative (e.g., cardiovascular, respiratory, neurologic, renal, etc.) complications during hospital stay following hepatectomy.

  7. Incidence of morbimortality at 90 days and 5 years following hypovolemic phlebotomy hepatectomy.

    Time frame: Postoperatively, from completion of surgery to 5 years post-operation.

    Track postoperative (cardiovascular, respiratory, neurologic, renal, etc.) complications as well as cancer recurrence at 90-day and 5-year postoperatively. Long-term (5-year) liver cancer recurrence will be compared to a historical local cohort as control. Measurement will be performed by phone call by research personnel.

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Sponsors and collaborators

Lead sponsor

Dr. Glenio Mizubuti (MD, PhD, FRCPC)

Other

Registry information

Official study title

Reducing Red Blood Cell Transfusion Requirements for Hepatectomy - A Quality Improvement Project

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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